Product efficacy does not drop below acceptable thresholds during storage.
The integrity of product packaging is maintained during storage.
Key indicators
Acceptable threshold for sealed product shelf life: 1 to 2 years.
Most desirable sealed product shelf life: 2 to 5 years.
Threshold efficacy: product must meet any microbial claims for the complete shelf life of the product.
Most desirable storage temperature range: -7°C to 60°C.
Storage humidity range: 30% to 100% RH.
Integrity of product is maintained and no maximum contaminant levels (MCLs) within treated water are exceeded due to product degradation or production of other chemicals.
Unsealed product should remain chemically stable and microbially efficacious for at least twice (safety factor = 2) the duration of the maximum user's consumption rate paired to the number of doses exposed upon breaking the product's seal.
Notes and exceptions
FMCG packaging is appropriate to foreseeable shipment and storage environments in target markets.
Halogenated disinfectants (e.g., bromine, chlorine) or other disinfectants (e.g., silver, zinc, copper, and permanganate) should retain chemical composition, retain the ability to inactivate microbial contaminants as claimed, not exceed any MCLs within treated water as noted by standards agencies, and maintain residual protection—ideally for 24 hours within treated water.
Frais S, Ng Y-L, Gulabivala K, et al. Some factors affecting the concentration of available chlorine in commercial sources of sodium hypochlorite. International Endodontic Journal. 2001;34(3):206–215.
Drinking Water Contaminants Maximum Contaminant Levels (MCLs) page. United States Environmental Protection Agency website. Available at: ww.epa.gov/safewater/contaminants/index.html.
